Get to know the standards
IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for a quality management system for medical devices.
ISO 14971 -standard
ISO 14971 is a key risk management standard for medical device manufacturers.
ISO 15189 -standard
ISO 15189 is the quality management standard for medical / clinical laboratories, which places the patient care perspective at its centre.
ISO 17025 -standard
The ISO 17025 standard for testing and calibration laboratories describes the general and technical requirements for the competent, impartial and consistent operation of laboratories.
ISO 27001 -standard
ISO 27001 is an internationally well-known information security standard.
ISO 62366-1 -standard
IEC 62366-1:2015 describes the processes for a manufacturer of medical devices to analyse, specify, develop and evaluate the usability of the medical device as it relates to safety.
Looking for a quality expert?
We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
IEC/EN 62304 Workshops and Training
The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.
Quality Management System Audits and Evaluations
Kasve’s service range includes internal audits which help you conform to a specific standard, and evaluations and plans that enable you to update your system to meet new requirements.
Quality Management Systems in the Health Industry
Kasve will help you build a quality management system that suits your organisation’s operations and supports your business in the optimal way.
Outsourced Quality Manager
Using an outsourced Quality Manager or a person responsible for regulatory compliance will provide more flexibility and free your organisation’s resources to its core activities.
Internal auditing training
The training organised by Kasve provides tools for successfully performing an internal audit and obtaining the qualifications required of persons performing audits.
Interpersonal skills training for auditors
This supplementary training for auditors provides participants with information and understanding of how people act in interactive situations.